Lead Verification and Validation Engineer

ZipRecruiter; England; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading company in London is seeking a Lead Verification & Validation Engineer for a 12-month contract. The role involves overseeing design outputs, leading verification testing, and ensuring compliance with regulatory standards. Ideal candidates will have experience in combination devices or pharmaceuticals and will thrive in a collaborative environment.

Qualifications

• Experience in verification and validation for combination devices or pharmaceuticals.
• Knowledge of relevant medical device and pharma labelling standards.

Responsibilities

• Oversight of design outputs and technical drawings.
• Lead design verification testing and design validation.
• Manage product change control and maintain design history files.

Skills

Collaboration

Design Verification

Regulatory Compliance

Job description

Job Description

Lead Verification & Validation Engineer | 12 month contract | £350-500 per day | Outside IR35 | London | Immediate start

One of my long-standing clients is looking for a V&V engineer as they transfer into manufacturing, ideally with a background in combination devices/pharmaceutical products.

They're based in London, but have a flexible working model. You'll be working closely with various heads of department to engender a collaborative and productive working environment.

They're true innovators into a critical area of unmet need, with a genuinely ground-breaking product.

Job overview:

• Oversight of completion of design outputs, including technical drawings, product and component specifications
• Oversight of the completion of labelling and packaging design in alignment with the relevant medical device and pharma labelling standards and regulations
• To lead the design reviews for the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS
• To lead the design verification testing of the device and associated labelling and packaging.
• Coordinate the supply of raw materials for the manufacture of DV samples
• Ensure test methods are documented, validated and staff are trained (training is recorded)
• Develop the design verification protocol, including traceability to the TRS and test reports
• Coordinate internal and external testing in accordance with the protocol
• Analyse test data and prepare a design verification report
• To lead the design validation of the device, including Clinical trials

• As above for design verification, plus:
• Liaison with the CRO, including the coordination of all documentation and evidence required for the clinical trial
• Maintain the design history file in accordance with 21 CFR part 820 requirements
• Manage product change control, in accordance with the relevant CLCC procedures
• Maintain the Device Master Record in accordance with 21 CFR part 820 requirements

Regulatory

• Collate the Technical File in accordance with the relevant regulations (could be UK, EU and / or US)

Please apply right away to be considered for this great opportunity.